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Novel Treatment Combination Improves Progression-Free Survival in Most Common Form of Metastatic Breast Cancer
Patients with estrogen-receptor-positive (ER+) HER-2-negative advanced breast cancer experienced significantly improved progression-free survival (PFS) when treated with an oral combination regimen that included giredestrant, a novel, next-generation selective ER degrader and full antagonist (SERD), compared to a standard combination approach.
The phase 3, randomized, open-label evERA study compared oral giredestrant plus everolimus with standard endocrine therapy plus everolimus in ER-positive, HER2-negative advanced breast cancer.
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Among 373 participants, approximately 55% had ESR1 mutations, and median follow-up was 18.6 months.
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In patients with ESR1-mutated tumors, median progression-free survival was 10 months with giredestrant plus everolimus and 5.5 months with standard therapy, a 63% lower risk of progression or death.
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In the intention-to-treat population, median progression-free survival was 8.8 months with giredestrant plus everolimus and 5.5 months with standard therapy, a 44% lower risk of progression or death.
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Overall survival data were immature, and the giredestrant regimen had a manageable safety profile consistent with the known profiles of the study treatments.